BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARISA

    MDR report key: 2253530 · Received September 13, 2011

    Report

    Report Number
    9611530-2011-00070
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION#(B)(4)) ON BEHALF OF THE MFR ARJO HOSP EQUIPMENT AB (REGISTRATION#9611530). PLEASE NOTED THAT THIS PRODUCT IS NO LONGER MFG AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO MED AB (B)(4) (UNDER REGISTRATION (B)(4)). AS OF (B)(4) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO HOSP EQUIPMENT AB AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS BEING TRANSFERRED FROM THE BED TO THE WHEELCHAIR WITH A MARISA LIFT WHEN THE INCIDENT OCCURRED; THE FACILITY STATES THAT THE LIFT MADE A POPPING NOISE, WHICH STARTLED THE PT AND CAUSED THEM TO MOVE AROUND IN THE SLING. DURING THIS, THE RIGHT LEG SLING CLIP CAME OFF AND THE PT SLID TO THE FLOOR, AND HITTING THEIR BACK ON THE LEG OF THE LIFT DURING THE PROCESS. THE PT SUFFERED A FRACTURE OF THE L5 VERTEBRAE AND WAS ADMITTED TO THE HOSP FOR X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARISA PASSIVE FLOOR LIFT FSA ARJO MED AB LTD KGA0200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization